36Kr Exclusive | Knee and Hip Implant Developer KuanYue Ortho Completes B+ Round Financing to Accelerate Global Expansion

36Kr has learned that b-ONE Ortho recently completed its B+ round of financing, exclusively invested by Pu Silver International Equity Investment Management (Shenzhen) Co., Ltd., with the Suzhou branch of SPD Bank providing M&A loans and revolving credit support to b-ONE Ortho. This round of financing will be used for the research and development of new materials for artificial joints, personalized prosthesis customization, and joint surgery robots; it will also continue to expand into international markets and accelerate the registration and listing of its products in different regions.

b-ONE Ortho was founded in 2015. Its founder and CEO, Jason Wang, previously worked at Johnson & Johnson's orthopedics division and served as the CFO of Kanghui Medical; its Chief Scientist, Dr. Mark Kester, formerly served as the Senior Global R&D Director at Stryker. Over the past six years, b-ONE Ortho has addressed pain points in joint replacement surgeries by improving the design of surgical implants and tools, and investing in innovative research in areas such as 3D printing technology, new biomaterials, and surgical robotics.

At the completion of the B+ round of financing, Wang Junwen, founder and CEO of b-ONE Ortho, and Chairman Yang Chongze accepted an interview with 36Kr, discussing the product technology innovation and commercial considerations of b-ONE Ortho.

Develop Innovative Joint Prostheses

Combining China's manufacturing capabilities with the technical expertise of international R&D teams to develop competitive artificial joint products isb-ONEThe entrepreneurial idea. Taking the knee joint as an example, its MOBIO system has received input and validation of requirements from doctors in multiple countries during the design process, with innovations in areas such as the patellofemoral joint interface, femoral curvature, posterior condyle morphology, and locking mechanisms. b-ONE is one of the few companies internationally that uses a single-radius femoral curvature design for joints. This design theory stems from the extensive experience of Chief Scientist Mark Kester, allowing patients to have a greater range of motion and better proprioception post-surgery.

By the end of 2021, in order to accelerate the product line layout,b-ONE Acquires Shanghai Shengshi Medical Device Technology Co., Ltd.(Hereinafter referred to as b-ONE Ortho). b-ONE Ortho, established in 1998, has a relatively complete product portfolio in the fields of limb joint replacement, oncology, and customized joint solutions. It has maintained a long-term collaboration with Academician Kerong Dai of the Chinese Academy of Engineering. In the 2021 National Artificial Joint Centralized Procurement in China, b-ONE Ortho's hip and knee joint products were successfully selected. After the completion of the acquisition, b-ONE became one of the few enterprises in China capable of offering comprehensive limb joint replacement solutions.

Currently, b-ONE's product line includesHip, Knee, Shoulder, Ankle, Wrist, Tumor, and Customized Artificial Joint Replacement Systems, as well as shape memory alloy fracture fixation solutions. Among them, multiple product lines are among the few domestically produced brands in China to have obtained registration certificates, such as wrist joint and ankle joint replacement systems. For example, the ankle joint replacement system, paired with the self-developed Insight+ personalized surgical osteotomy system, has already been utilized in surgeries at several large tertiary hospitals in China. In the field of shoulder joints, b-ONE offers a complete solution including an integrated hemi-shoulder joint, standard shoulder replacement system, and reverse shoulder replacement system.

In addition, in the field of oncology and personalized custom implants, benefiting from the years of technical accumulation by Shine Medical, b-ONE can currently provide a complete solution, including limb-sparing solutions for bone tumors in various parts of the limbs such as the pelvis, femur, tibia, calcaneus, humerus, scapula, phalanges, and ulna and radius.

Innovative Technologies: 3D Printing, New Materials, and Surgical Robots

In addition to continuously improving the implant product line, b-ONE has also maintained ongoing investment in innovative technologies, including 3D printing technology, new wear-resistant materials, and robotic joint surgery.

3D printing technology, as a new generation of manufacturing technology, can effectively solve the cross-sectional integration issue between bone and metal materials in the field of artificial joints.Therefore, it has gained the attention and investment of R&D from major enterprises. For b-ONE, on the one hand, 3D printing technology is beneficial for developing high-performance conventional prostheses, and on the other hand, it is also crucial for improving the customization efficiency and performance of personalized prostheses.

"The 3D printing technology developed by the b-ONE international team can be used for printing porous surface structures. Through optimized topological structure design, the pore size distribution of the porous surface is similar to the distribution of the internal structure of human cancellous bone, featuring randomness while conforming to statistical distribution, rather than the commonly seen uniform mesh structure," introduced Yang Chongze. Currently, b-ONE's 3D printing technology can primarily benefit relatively complex cases such as poor bone quality, bone loss, severe deformities, and tumors. As the technology iterates and improves, it will gradually allow regular patients to use personalized and precise implant systems, showing considerable market potential.

One of the long-term issues with artificial joints lies in the wear and tear of the implants.After the prosthesis is implanted into the human body, it needs to be accompanied by movement for decades. The failure of the friction interface means the failure of the prosthesis, requiring revision surgery. To address the issue of wear, b-ONE is developing a new material with the internal code name "Sapphire Polyethylene" to achieve long-lasting durability.

This material utilizes gradient cross-linking technology, introducing an ultra-high equivalent irradiation cross-linking degree on the critical friction interface of artificial joints, thereby achieving superior wear resistance. As the material depth increases, the cross-linking degree gradually decreases, maintaining the material's mechanical toughness and strength. Studies have shown that the material’s wear performance in water is higher than that of several highly cross-linked polyethylene components and close to the wear data of ceramic components, while its mechanical toughness is better than that of ceramics, making it possible to design and manufacture ultra-thin and super wear-resistant new artificial joint prostheses. Currently, the acetabular liner component developed based on this material has been submitted for FDA approval.

Robotic-assisted joint replacement surgery is another developmental direction in the field of artificial joints.According to Wang Junwen, the founder of b-ONE, the surgical robot developed by b-ONE has completed the surgical portion of its clinical trials and is currently collecting final post-operative feedback. It is expected to be approved and enter the market by the summer of 2023.

"The design concept of b-ONE Ortho's surgical robot is to make it affordable for hospitals and clinicians who need it." Therefore, from the initial product design, this surgical robot did not adopt the large mechanical arms commonly used in traditional multi-million-dollar models. Instead, it achieves high positioning accuracy at a lower cost, meeting specific surgical requirements while being protected by patents. The surgical robot was co-developed and rapidly iterated with partners such as the First Affiliated Hospital of Xinjiang Medical University and the First Affiliated Hospital of Zhejiang University School of Medicine to align with the surgical habits and philosophies of most doctors in China.

Team and Commercialization

At present, b-ONE Ortho has a global team of approximately 200 people, including about 70 in the sales and marketing team, around 100 in R&D, operations, and factory production, and approximately 20 in the management team. Additionally, b-ONE Ortho has four factories in Beijing, Shanghai, Suzhou in China, and New Jersey in the United States, as well as two R&D centers established in both China and the U.S.

In terms of the commercialization of joint implants, according to Wang Junwen, in China, since the formal commercialization of b-ONE products began in early 2019, they have covered hundreds of hospitals. Meanwhile, both hip and knee products have been selected in the national centralized procurement of artificial joints, gaining the qualification for hospital entry, with the potential to expand to more hospitals. In the international market, the products have entered more than ten countries, including Southeast Asia, Latin America, and Africa, and are preparing to expand into markets such as Japan, South Korea, and the Middle East. In 2023, b-ONE...Sales revenue from joint implants in overseas markets is expected to exceed ten million US dollars., becoming another growth engine following the Chinese market.

In addition, "b-ONE's surgical robot will enter the market next year. For hospitals, surgical robots and matching joint prostheses are two complementary aspects to improve surgical outcomes. The sales and installation of surgical robots are expected to increase the clinical use of joint prostheses," said Wang Junwen. "At the same time, a complete product line covering different departments and indications can create an overall effect, serving and responding to hospital needs more efficiently, further improving hospital coverage efficiency and increasing per-hospital output."

Currently, about 120 million people in China suffer from arthritis, and 55% of seniors aged 60 and above are affected by the condition. Against the backdrop of an increasingly aging population, "The internal growth momentum of China's orthopedic joint industry is strong, and it is about to enter a high-speed development window. b-ONE has a comprehensive business layout, with products that boast international competitiveness and complete patents. These products not only achieve domestic substitution in the Chinese market but have also won recognition from renowned overseas clients such as New York's Mount Sinai Hospital. Pu Silver International will leverage Hong Kong's advantages as an international financial and technology innovation hub to connect b-ONE with premium R&D and capital market resources, helping it become a world-class leading orthopedic company."Dr. Jia Hongrui, CEO of Pu Silver International Equity Investment Management(Shenzhen)Co., Ltd., the investor of this round, stated.